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US Senators Question FDA's Pre-Cert Program Authority, Concerned About Safety

Top Democratic lawmakers on the Senate HELP Committee have written to US FDA Commissioner Scott Gottlieb with questions about the agency's ongoing work to develop a pre-certification program that would allow medical software-makers to gain the agency's trust as a means to benefit from reduced or no pre-market review.

Capitol House

Three top Democratic Senators on the US Senate Health, Energy, Labor and Pensions Committee (HELP) want answers on US FDA's planned pre-certification program; they've sent Commissioner Gottlieb an extensive list of questions on the subject. The lawmakers are concerned the agency may be moving forward without proper statutory authority and are concerned the program may not provide the oversight needed to ensure medical software products meet the agency's level of safety and efficacy.

The agency has been developing the program, which remains in a pilot phase, for about the past two years. The concept was for FDA to let software developers bring SaMDs...

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